Position Summary:

Responsibility for document control, issuance, maintenance and related tasks

Reporting Structure:

Reports to Associate Director of Quality Assurance

Direct Reports:

N/A

Major Responsibilities:

· Initiation, issuance, and implementation of document change notices

· Maintenance of training records

· Maintenance approved supplier files

· Maintenance of quality system documentation and records

· Documentation filing and archiving

· Distribution of various types of controlled documentation

· Responsible for the maintenance of the various logs (i.e., CAPA, NCM, Complaints, Protocol number assignment, etc.)

Secondary Responsibilities:

· Support Quality Control activities as needed

· Creation and maintenance of quality trending data

· Purchasing of routine office and manufacturing supplies

· Perform special tasks per request of the Associate Director of Quality Assurance

Education:

· HS Diploma, GED or equivalent preferred

Experience:

· A minimum of 2 years experience in the medical device industry preferred, but not required.